The Food and Drug Administration announced Friday it is halting sales of unapproved ingestible fluoride prescriptions for children age 3 or younger who have a low or moderate risk of tooth decay.

The FDA said it notified four companies to stop marketing the products, noting they have never been approved for safety, effectiveness or quality. The agency said the products increase the risk of altering the gut microbiome and have shown no benefit in reducing cavities among infants.

When the FDA first proposed the action, the American Dental Association criticized the move, saying ingestible fluoride tablets play a critical role in preventing tooth decay among children in rural communities.

“In non-fluoridated communities, especially rural areas, fluoride supplements are the only chance for

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